Prescription drug · ANDA
Idarubicin Hydrochloride NDC 71288-184
Idarubicin hydrochloride 1 mg/mL · Injection, Solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-184-05 | 7128801840571288018405 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-184-05) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Idarubicin Hydrochloride
- Generic name (nonproprietary)
- idarubicin hydrochloride
- Active ingredients
- Idarubicin hydrochloride — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065036
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-184_677002b4-7b30-4d32-ae99-5ee630c5b5fbSPL ID 677002b4-7b30-4d32-ae99-5ee630c5b5fbSPL set ID d31254be-6bd2-4ac1-acab-bc00e2209d28RxCUI 1791493, 1791498, 1791500UNII 5VV3MDU5IE
- Pharmacologic class
- Anthracycline Topoisomerase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471288018405followed by a unit qualifier and the quantityPackage 71288-0184-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.
Excerpt only. Read the full label for complete information.
About NDC 71288-184
- What is NDC 71288-184?
- 71288-184 is the product NDC for Idarubicin Hydrochloride, Idarubicin hydrochloride 1 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Idarubicin Hydrochloride.
- What is the active ingredient?
- Idarubicin hydrochloride.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Idarubicin Hydrochloride?
- 8 other product NDCs are listed under this name. See all Idarubicin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Idarubicin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-185 | 71288-0185-10 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-186 | 71288-0186-20 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9306 | 00143-9306-01 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9307 | 00143-9307-01 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9308 | 00143-9308-01 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9217 | 00143-9217-01 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9218 | 00143-9218-01 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9219 | 00143-9219-01 |
Other NDCs under ANDA 065036
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-185 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-186 |